Lung Transplantation
Conditions
Keywords
Lung transplantation, ExVivo reconditionning
Brief summary
Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list. A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition marginal and nonacceptable donor lungs. After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.
Interventions
DEVICEXvivo Chamber
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients on the waiting list for lung transplantation and for which the Biomedicine -Agency has awarded a lung transplantation after Ex-Vivo lung reconditioning * Patients affiliated to a social security system; * Patients who consented to participate in writing
Exclusion criteria
-Patients under tutorship or unable to consent or institutionalized
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of transplantable grafts and Reduced waiting time before transplantation | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Difference of data obtained 2 hours after Ex-Vivo lung reconditioning with those obtained 4 hours after Ex-Vivo lung reconditioning | 4 hours after Ex-Vivo lung reconditioning |
| Number of deaths of patients on waiting list | 5 years |
| survival time after lung transplantation with ExVivo lung reconditioning | 1 year after end of study |
| Quality of life scale score after lung transplantation with ExVivo lung reconditioning | 1 year after end of study |
Countries
France
Outcome results
None listed